By Nancy L. Geller
From points of early trials to complicated modeling difficulties, this helpful reference summarizes present method utilized in the layout and research of scientific trials. Chapters are contributed via the world over respected methodologists skilled in medical trials perform.
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Extra resources for Advances in Clinical Trial Biostatistics
The concept itself is simple, * Nancy L. Geller, Dean Follmann, and Eric Leifer wrote this chapter in their private capacity. The views expressed in the chapter do not necessarily represent the views of NIH, DHHS, or the United States. Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. 42 Geller et al. but has not found widespread application. While the phase I/II portion may use any of the designs in the literature, we have nested the phase I escalation portion into frequentist phase II designs with early stopping rules.
Oxford University Press. , Chen, T. , Tyan, I. (2000). Designs for phase I cancer clinical trials with diﬀerentiation of graded toxicity. Communications in Statistics—Theory and Methods 29:975–987. Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. Bayesian Methods for Cancer Phase I Clinical Trials 39 Watson, A. , Pelli, D. G. (1983). QUEST: A Bayesian adaptive psychometric method. Perception and Psychometrics 33:113–120. Whitehead, J. (1997). Bayesian decision procedures with application to doseﬁnding studies.
1990) utilized Bayesian inference. Subsequently, to overcome certain diﬃculties associated with the Bayesian approach (see, for example, Gasparini and Eisele, 2000) a maximum likelihood based version of CRM (CRML) was introduced (O’Quigley and Shen, 1996). Essentially, the Bayesian and likelihood based approaches diﬀer with respect to the method used to estimate the probability of DLT at each permissible dose level. Thus, for example, both CRM and CRML might utilize the estimates given by Eq.